AMSTERDAM, THE NETHERLANDS--(Marketwired - September 03, 2013) - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that a new post-hoc data analysis from The PARTNER Trial demonstrated that diabetic patients with aortic stenosis in need of heart valve replacement, but at high surgical risk, experienced a 35 percent(1) lower relative all-cause mortality one year after treatment with transcatheter aortic valve replacement (TAVR), as compared to those treated with surgical aortic valve replacement (AVR).
The data analysis was presented today at the ESC Congress 2013 in Amsterdam by Brian Lindman, M.D., assistant professor of medicine, cardiovascular division, at Washington University School of Medicine in St. Louis.
"While this was not a pre-specified analysis of the trial and should be considered hypothesis generating, our study raises the possibility that TAVR may be the preferred approach for diabetic patients with severe symptomatic aortic stenosis who are at high surgical risk," said Lindman, who participated in The PARTNER Trial as a clinical investigator.
In the analysis of diabetic patients in the as-treated high-risk cohort of The PARTNER Trial, one-year all-cause mortality was 18 percent for patients treated with the Edwards SAPIEN valve delivered via the femoral artery or a small incision between the ribs, and 27.4 percent for patients treated with surgical aortic valve replacement. Additionally, the analysis showed that diabetic patients treated with TAVR experienced quicker quality of life improvement and lower one-year rates of renal failure than those treated with surgery.
The PARTNER Trial is the first randomized, controlled trial of a transcatheter aortic valve in the United States. The trial's high-risk cohort (Cohort A) included an as-treated population of 657 patients with severe, symptomatic aortic stenosis deemed at high risk for traditional open-heart surgery. Of those, 275 were diabetic and treated with either TAVR (n=145) or surgical AVR (n=130). The post-hoc analysis did not account for diabetic medications, severity/duration of diabetes, microvascular complications or glucose control. Lindman concluded that further studies are needed to understand how insulin treatment or the presence of metabolic syndrome may influence outcomes.
The Food and Drug Administration (FDA) approved the SAPIEN valve in November 2011 for the treatment of inoperable patients, and expanded the indication to high-risk surgical patients in October 2012.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring, enabling them to save and enhance lives. Additional company information can be found at www.edwards.com.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements include, but are not limited to, Dr. Lindman's statements. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.
Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors, including but not limited to, the possibility that future clinical could yield different results. These factors are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2012.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, PARTNER and SAPIEN are trademarks of Edwards Lifesciences Corporation.
(1) All percents for data in this press release are Kaplan-Meier estimates.